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Completed

NCT Number: NCT00759941

A Comparison of Azopt Versus Placebo Added to Xalatan in Patients With Elevated Intraocular Pressure (IOP) on a Prostaglandin

The purpose of this study was to assess the efficacy of adding Azopt dosed three times a day to Xalatan as compared to that of adding placebo to Xalatan in patients with elevated intraocular pressure.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unilateral or bilateral primary open angle glaucoma, ocular hypertension or pseudoexfoliation syndrome.
  • Intraocular pressure greater than 18 mmHg (mean diurnal) and less than 32 mmHg.
  • Other protocol-defined inclusion criteria applied.

Exclusion:

  • Previous intraocular surgery, except uncomplicated clear cornea phacoemulsification or argon laser trabeculoplasty.
  • Argon laser trabeculoplasty or phacoemulsification within the last 3 months.
  • Central corneal thickness outside the 500 - 600 (inclusive) micron range as measured by ultrasonic pachymetry.
  • Ocular or periocular inflammation within 3 months prior to study (except blepharitis related or seasonal allergic conjunctivitis).
  • History of uveitis or previous intraocular inflammation (other than post-operatively).
  • Hypersensitivity to sulfa, or benzalkonium chloride.
  • History of use of any steroids for over 1 week within 3 months of screening or likely need for any corticosteroids during the study (except inhaled, nasal or topical non-ocular).
  • Other protocol-defined exclusion criteria applied.

Treatment and study plan

Brinzolamide 1% ophthalmic solution (Azopt)

Drug

One drop three times a day in both eyes for 3 months

Other names: AZOPT

Placebo Eye Drops

Drug

One drop three times a day in both eyes for 3 months

Latanoprost 0.005% Ophthalmic Solution (XALATAN)

Drug

One drop once a day in both eyes for 3 months

Other names: Xalatan

Primary outcomes

  1. Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months

    Time frame: Day 0, 3 months

    Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.

  2. Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months

    Time frame: Day 0, 3 months

    Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.

  3. Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months

    Time frame: Day 0, 3 months

    Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.

  4. Mean Change From Baseline in Intraocular Pressure, Diurnal, at 3 Months

    Time frame: Day 0, 3 months

    Diurnal intraocular pressure is the mean of the three timepoints measured (8AM, 12PM & 4PM). Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in mean intraocular pressure.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

A Comparison of Brinzolamide Ophthalmic Suspension, 1% (Azopt) TID vs. Placebo TID Added to Latanoprost Ophthalmic Solution, 0.005% (Xalatan) in Patients With Elevated IOP on a Prostaglandin

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 25, 2008
Registry last updated
Jan 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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